Malocclusion, Angle Class IINCT06984666
Facial Aesthetic Analysis Model Based on Clinical Cohort Phenotype to Explore 45° Facial Profile.
A study testing language in people with Malocclusion, Angle Class II and Malocclusion, Angle Class III, run by Linyu Xu at 1 site in China.
Trial summary
Facial aesthetics has always been a complex and subjective concept. The overall facial harmony, along with lip protrusion, which is often a focus for orthodontists, requires evaluation from multiple perspectives. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class II, Malocclusion, Angle Class III
- What is being tested?
- language
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Orthodontist inclusion criteria: ① With dental doctor qualification certificate; ② At least 2 years of professional training in orthodontics.
- Inclusion criteria for orthodontic patients: ① Receiving orthodontic treatment for more than 1 year; ② Volunteer to participate in the study; ③ Native language is Chinese, can understand the prompt language and normal communication.
- General adult inclusion criteria: ① have not experienced orthodontic treatment or have no need for orthodontic treatment; ② Do not engage in stomatology industry, have not studied stomatology specialty; ③ Native language is Chinese, can understand the prompt language and normal communication.
Who cannot join
- ① have visual impairment (such as color blindness, high myopia); ②Have psychological problems (such as autism, schizophrenia); ③ Recent use of alcohol, or long-term fatigue, anxiety; Current use of any medication that may affect cognitive ability; ⑤ Use mascara, contact lenses or small frame height glasses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Stomatological Hospital Affiliated with Fujian Medical University
Fuzhou, Fujian, 350025
About this study
Official title: The Perception of Lower Third of the Face Combined With Digital Virtual Models and the Clinical Phenotype at 45° Viewing Angle : a Clinical Study
Facial aesthetics has always been a complex and subjective concept. The overall facial harmony, along with lip protrusion, which is often a focus for orthodontists, requires evaluation from multiple perspectives. The viewing angle also influences the assessment of facial aesthetics, particularly the judgment of lip protrusion. This study aims to explore the differences in facial fixation patterns and aesthetic evaluations among different populations at specific viewing angles by using digital models to simulate various perspectives.
Read the detailed description
In the analysis of facial aesthetics, the 45° profile has a unique advantage in evaluating lip protrusion, zygomatic fullness, and contour curve. Compared to the frontal view, this angle provides a more three-dimensional and deeper perspective. In a previous study, the research group found that the shape of the midface area at 45° influences the evaluation of lip protrusion. In this study, a digital model was used to simulate the protrusion of different midface areas in order to explore the differences in facial fixation patterns and aesthetic evaluations among various individuals at 45°. Based on data from individuals who showed significant improvement in frontal and profile beauty before and after clinical treatment, the study added an evaluation of beauty and lip position from the 45° profile. This aims to provide a reference for the subsequent establishment of a 45° profile analysis.
- Being tested
- language
- Keywords
- Midface, Eye tracking, Aesthetic evaluation, Perception, morphology
- Medical subject headings
- Malocclusion, Angle Class II, Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
languageBehavioural
Language cues are used to provide participants with psychological suggestions in order to achieve the goal of shifting their focus in gaze patterns.
| Study group | Role | What they receive |
|---|---|---|
| Free browsing | No intervention | This phase of the experiment serves as baseline data without language intervention. |
| Language cue | Experimental | In this phase of the experiment, participants are given language cues to intervene in their eye movement. Receives: Behavioral: language |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fixation duration of area of interest
The facial images used as stimulus materials are divided into several regions, with the fixation duration in each area of interest serving as the primary measurement. Changes in fixation duration represent a shift in the focus of attention.
Measured: The duration of the experiment for each participant does not exceed 10 minutes. A random selection of 10 participants will immediately undergo a repeat experiment after the first round to verify the reliability of the participants.
Secondary outcomes (1)
Eye movement track
The specific patterns of attention shift will be further observed through the changes in eye-tracking trajectories.
Measured: The duration of the experiment for each participant does not exceed 10 minutes.A random selection of 10 participants will immediately undergo a repeat experiment after the first round to verify the reliability of the participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Oct 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linyu Xu
- Sponsor type
- University, hospital or other
- Collaborators
- Stomatological Hospital Affiliated with Fujian Medical University
- Responsible party
- Sponsor-investigator, Linyu Xu, Stomatological Hospital Affiliated with Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984666
- Sponsor's protocol ID
- 2024Clin003
- Status last verified
- Sep 2024
- First submitted
- 14 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are concerns about excessive patient privacy intrusion, and some patients are unwilling to provide all the requested information, such as unmasked facial data and other sensitive details.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perception of Lower Third of the Face Combined With Digital Virtual Models and the Clinical Phenotype at 45° Viewing Angle : a Clinical Study
- ClinicalTrials.gov ID
- NCT06984666
- Acronym / sponsor ID
- 2024Clin003
- Keywords
- Midface, Eye tracking, Aesthetic evaluation, Perception, morphology
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Linyu XuUniversity, hospital or other
- Collaborators
- Stomatological Hospital Affiliated with Fujian Medical University
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Facial aesthetics has always been a complex and subjective concept. The overall facial harmony, along with lip protrusion, which is often a focus for orthodontists, requires evaluation from multiple perspectives. The viewing angle also influences the assessment of facial aesthetics, particularly the judgment of lip protrusion. This study aims to explore the differences in facial fixation patterns and aesthetic evaluations among different populations at specific viewing angles by using digital models to simulate various perspectives.
Detailed description
In the analysis of facial aesthetics, the 45° profile has a unique advantage in evaluating lip protrusion, zygomatic fullness, and contour curve. Compared to the frontal view, this angle provides a more three-dimensional and deeper perspective. In a previous study, the research group found that the shape of the midface area at 45° influences the evaluation of lip protrusion. In this study, a digital model was used to simulate the protrusion of different midface areas in order to explore the differences in facial fixation patterns and aesthetic evaluations among various individuals at 45°. Based on data from individuals who showed significant improvement in frontal and profile beauty before and after clinical treatment, the study added an evaluation of beauty and lip position from the 45° profile. This aims to provide a reference for the subsequent establishment of a 45° profile analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free browsing | No intervention | –This phase of the experiment serves as baseline data without language intervention. |
| Language cue | Experimental | Behavioral: languageIn this phase of the experiment, participants are given language cues to intervene in their eye movement. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Orthodontist inclusion criteria: ① With dental doctor qualification certificate; ② At least 2 years of professional training in orthodontics.
- Inclusion criteria for orthodontic patients: ① Receiving orthodontic treatment for more than 1 year; ② Volunteer to participate in the study; ③ Native language is Chinese, can understand the prompt language and normal communication.
- General adult inclusion criteria: ① have not experienced orthodontic treatment or have no need for orthodontic treatment; ② Do not engage in stomatology industry, have not studied stomatology specialty; ③ Native language is Chinese, can understand the prompt language and normal communication.
Key exclusion criteria (1 listed)
- ① have visual impairment (such as color blindness, high myopia); ②Have psychological problems (such as autism, schizophrenia); ③ Recent use of alcohol, or long-term fatigue, anxiety; Current use of any medication that may affect cognitive ability; ⑤ Use mascara, contact lenses or small frame height glasses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| languageLanguage cues are used to provide participants with psychological suggestions in order to achieve the goal of shifting their focus in gaze patterns. | Behavioural | Language cue |
Primary outcome
Total fixation duration of area of interest
Time frame: The duration of the experiment for each participant does not exceed 10 minutes. A random selection of 10 participants will immediately undergo a repeat experiment after the first round to verify the reliability of the participants.
The facial images used as stimulus materials are divided into several regions, with the fixation duration in each area of interest serving as the primary measurement. Changes in fixation duration represent a shift in the focus of attention.
1 secondary outcome
Eye movement track
Time frame: The duration of the experiment for each participant does not exceed 10 minutes.A random selection of 10 participants will immediately undergo a repeat experiment after the first round to verify the reliability of the participants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No. There are concerns about excessive patient privacy intrusion, and some patients are unwilling to provide all the requested information, such as unmasked facial data and other sensitive details.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing language in people with Malocclusion, Angle Class II and Malocclusion, Angle Class III, run by Linyu Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fixation duration of area of interest (time frame: The duration of the experiment for each participant does not exceed 10 minutes. A random selection of 10 participants will immediately undergo a repeat experiment after the first round to verify the reliability of the participants.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.